16 results
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7ms
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Sources: EU EUDAMED, US FDA
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 21, 2025
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·May 23, 2018
Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·August 29, 2018
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·February 13, 2019
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·August 18, 2021
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
FDA Enforcement
Class II
·Ongoing·Richard Wolf GmbH·May 3, 2023
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight conditions for the excision of polyps and/or the removal of tumors that have been previously staged.
FDA Enforcement
Class II
·Terminated·Richard Wolf GmbH·August 5, 2020
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0
FDA Enforcement
Class II
·Ongoing·Wolf, Henke Sass, Gmbh·October 4, 2023
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·July 10, 2024
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·December 5, 2018
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·October 9, 2019
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
FDA Enforcement
Class II
·Ongoing·WOM World of Medicine AG·October 6, 2021